Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome

A Comparative Analysis of the Efficacy of Ultrasound-Guided Injection of 5% Dextrose in Water for the Treatment of Mild to Severe Carpal Tunnel Syndrome

This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kastamonu, Turkey, 37150
    • Gamze Gül Güleç

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
2. Sensory loss with numbness in the median nerve-innervated regions of the hand.
3. Weakness with atrophy of the median nerve-innervated thenar muscles.
4. Positive Phalen's test and/or Tinel's sign.
5. The diagnosis should be confirmed with electrodiagnostic studies.

Exclusion Criteria:

1. History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
2. History of systematic infection, and rheumatologic disorders.
3. Previous steroid injection for carpal tunnel syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Mild Carpal Tunnel syndrome	Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection; Under the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons.
Active Comparator: Group 2; Moderate Carpal Tunnel Syndrome	Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection; Under the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons.
Active Comparator: Group 3; Severe Carpal Tunnel Syndrome	Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection; Under the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale(VAS)	VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line. The Turkish version of the assessment has been validated and shown to be reliable.	At the beginning, 1.,4., 12. week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)	The Boston Carpal Tunnel Questionnaire (BCTQ) comprises two subscales. The Symptom Severity Scale provides data on symptom intensity, while the Functional Status Scale assesses hand function. The Symptom Severity Scale comprises 11 items evaluating pain, paresthesia, numbness, weakness, night symptoms, and difficulty grasping. Meanwhile, the Functional Status Scale includes eight items assessing functional deficits in writing, buttoning clothes, holding a book while reading, gripping a phone handle, opening jars, performing household chores, carrying a shopping bag, bathing, and dressing. Each item is scored from 1 (no symptoms/no difficulty) to 5 (worst symptom or cannot perform the activity at all). The average score of each scale yields a score between 1 and 5, with higher scores indicating more severe symptoms or functional impairments.A Turkish validity and reliability study has been conducted.	At the beginning, 1.,4., 12. week
Dolour Neuropathique en 4 Questions (DN4) questionnaire	The DN4 (Dolour Neuropathique en 4 Questions) questionnaire is a screening tool designed to aid in diagnosing neuropathic pain. Developed in 2005, it consists of ten items, with seven questions focusing on sensory symptoms and three on signs related to neuropathic pain. The questions cover various characteristics of neuropathic pain, such as burning, tingling, and sensitivity to touch. Turkish validity and reliability measures were established for its use.	At the beginning, 1.,4., 12. week

Collaborators and Investigators

• Sponsor: Kastamonu University
• Investigators: Study Chair: Emre Özmen, İstanbul Physical Medicine and Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): March 2, 2024

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; ultrasound; dextrose
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No